BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 4977388 · Received August 6, 2015

    Report

    Report Number
    1710034-2015-00001
    Event Type
    Injury
    Date Received
    August 6, 2015
    Date of Event
    July 20, 2015
    Report Date
    August 6, 2015
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED FOR THIS INCIDENT. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A BD INSYTE⠁AUTOGUARD⠂BC SHIELDED IV CATHETER, THE SAFETY MECHANISM WAS ACTIVATED, THE NEEDLE RETRACTED APPROPRIATELY, BUT A PORTION OF THE DEVICE WAS SHARP ENOUGH TO CAUSE A BREAK IN THE RN'S SKIN AND HE/SHE WAS EXPOSED TO A PATIENT'S BLOOD. THE RN RECEIVED ROUTINE POST EXPOSURE LAB WORK AND A TDAP IMMUNIZATION BUT DECLINED ANY FURTHER MEDICAL INTERVENTIONS. THE RN WILL CONTINUE TO BE MONITORED AND HAVE FUTURE LAB WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519909 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention